Ocular Therapeutix (OCUL) UBS Virtual Ophthalmology Day summary

Vision and leadership

• Leadership assembled a highly experienced team to address a clear regulatory path and unique product opportunity in sustained delivery for retinal diseases.

• Recruitment for clinical trials has been outstanding, attributed to effective communication and team expertise.

Product mechanism and differentiation

• The therapy is a potent intracellular pan-VEGF tyrosine kinase inhibitor, about 200 times more potent than others in development.

• Utilizes a hydrogel platform for synchronized drug and carrier clearance, avoiding stacking issues and supporting extended duration of effect (at least 10 months).

Clinical trial design and regulatory feedback

• SOL-1 is a superiority study and SOL-R is a non-inferiority study, both designed to align with FDA guidelines and maximize commercial flexibility.

• FDA provided written confirmation that both SOL-1 and SOL-R are sufficient for approval, with no need for additional studies.

• SPA agreement and Type C written response from FDA validate the regulatory path and trial design, with explicit rejection of sham injections as proper masking.